Sanochemia Pharmazeutika AG, whose shares are traded in the Prime Segment of the Frankfurt Stock Exchange, reports that its U.S. Partner Avigen, Inc., (Nasdaq:AVGN) a biopharmaceutical company innovating therapeutics for the treatment of neurological conditions, announced the initiation of a Phase II trial for AV650 (tolperisone HCL) in the treatment of spasticity associated with multiple sclerosis (MS). This phase II spasticity trial will evaluate the safety, tolerability and efficacy of AV650 in MS patients at doses up to 900mg for one month followed by an open-label safety extension. The trial will be conducted in centers in Germany and several other European countries. “Our development plans for AV650 in North America have been designed to leverage the clinical experience of Tolperisone in many European countries where the drug is currently approved,” said Kenneth Chahine, Ph.D., J.D., Avigen president and chief executive officer. “This trial complements our U.S. development program by giving us direct experience with doses up to 900mg and validating the efficacy of the compound. This study will also allow us to begin accumulating long-term safety data needed for commercialization.”
Avigen is developing AV650 for commercialization in the North American market for the treatment of disabling neuromuscular spasticity and spasm under a license and supply agreement with Sanochemia Pharmazeutika AG. AV650 is considered a New Chemical Entity (NCE) in the United States. Tolperisone is an orally administered, centrally-acting small molecule marketed for the treatment of neuromuscular spasticity and spasm in Europe and Asia. Avigen’s U.S. development program is designed to build on the extensive ex-U.S. safety and efficacy experience with this compound. Versions of Tolperisone have been approved for marketing in Germany for over 10 years. Sanochemia and its European marketing partner, Orion, have recently received approval for marketing a proprietary 150mg tablet formulation of tolperisone in Germany under the brand name Viveo® which is expected to be launched later in 2007.
According to the National Multiple Sclerosis Society, MS affects more than 2.5 million people worldwide. Spasticity is considered one of the main symptoms of MS, affecting up to 60 per cent of this population. Randall Shapiro M.D, Director of the Fairview Multiple Sclerosis Center in Minnesota, and a leading researcher of MS, commented “there is a definite need for better-tolerated, non-sedating therapies in the United States for MS patients suffering from spasticity and we are encouraged with the European experience of tolperisone.”
About the Trial
This double blind, randomized clinical trial will be conducted in 25 MS centers in Germany and other European countries. It will evaluate safety, tolerability, pharmacokinetics and efficacy in MS patients suffering from spasticity. This trial will be conducted to Good Clinical Practice standards by a leading international contract research organization. Following a 4-week double blind assessment, patients will be offered the opportunity to continue in a six month open label safety assessment. The primary endpoint will be the Ashworth scale, a standard tool used in the clinic to measure increased movement, with secondary endpoints including Brief Pain Index (BPI), painful spasm diaries, and clinical impression of change.
AV650 (Tolperison) Development Progress
- Avigen’s AV650 Phase II trial in spasticity following spinal cord injury is underway in multiple centers in the US and is expected to report in the second half of 2008.
- Sanochemia has discontinued development of the initial controlled release formulation of tolperisone because it did not achieve the desired pharmacokinetics for a twice-a-day product. Avigen and Sanochemia are assessing next steps for controlled release alternative formulations.
About AV650 (Tolperisone)
AV650 is being developed in the North American market for the treatment of disabling neuromuscular spasticity and spasm under a license and supply agreement with Sanochemia Pharmazeutika AG. Tolperisone is an orally administered centrally acting small molecule marketed for the treatment of neuromuscular spasticity and spasm in Europe and Asia, including Germany, Switzerland, Austria, and Japan. Avigen's development program is designed to build on the extensive ex-U.S. safety and efficacy experience with this compound.
About Neuromuscular Spasm and Spasticity
Chronic or recurrent muscle spasm is a sudden, violent, painful contraction of muscles typically associated with serious neurological disorders such as Lou Gehrig's disease (ALS), multiple sclerosis, stroke, spinal cord injury, and cerebral palsy. These painful muscle spasms are often, but not always, associated with spasticity, an abnormality in muscle "tone". Spastic limbs become stiff and rigid because the muscles fail to relax, lacking normal regulation by the damaged nervous system. Both spasticity and sudden, painful muscle spasms can occur as complications of the neurological disorders mentioned above. Spasticity is a common symptom in multiple sclerosis, which affects 2.5 million worldwide.
About Sanochemia
Sanochemia Pharmazeutika AG is a specialty pharmaceutical company with outstanding development skills and its own API production facilities. The company has elected to focus on the areas of the central nervous system, pain, oncology and clinical diagnostics – indication areas with high therapeutic demands and urgent medical need for new and innovative drugs as the means to improving patient quality of life.
In its manufacturing activities, Sanochemia concentrates on the development of complex synthetic APIs. Sanochemia is the exclusive supplier to Janssen-Cilag of synthetic galantamine – a substance used in the treatment of Alzheimer’s disease. A liposomal form of galantamine is currently in clinical trials for the indication neuropathic pain. Tolperisone, a drug for the treatment of neuromuscular spasms, is already approved in Germany to treat spasticity associated with neurological disorders such as stroke and multiple sclerosis. This German approval is the stepping stone for additional European approvals through the Mutual Recognition Procedure (MRP). To learn more about Sanochemia, please visit our website, www.sanochemia.at.
About Avigen
Avigen is a biopharmaceutical company focused on unique small molecule therapeutics and biologics to treat serious neurological disorders, including neuropathic pain and neuromuscular spasm and spasticity. Avigen's strategy is to complete the requirements of clinical development for each of the candidates in its product pipeline, and continue to look for opportunities to expand its pipeline through a combination of internal research, acquisitions, and in-licensing, with the goal of becoming a fully integrated commercial biopharmaceutical company committed to its small molecule and biologics neurology products. The company currently has in development AV650 for neuromuscular spasm and spasticity and AV411 for neuropathic pain. Additionally, the company has in development a compound for the treatment of hemophilia A and B, AV513. For more information about Avigen, consult the company's website at www.avigen.com.
For further information please contact:
Margarita Hoch Investor Relations
Phone: +43 / 1 / 3191456 / 335 Fax: +43 / 1 / 3191456/ 344
Mailto: m.hoch(at)sanochemia.at
www.sanochemia.at
Sanochemia: US-Partner Avigen commences multicentric phase II study in the development programme for tolper...
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